Oral Assent Script_U.S.

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Submit Consent Documents in Microsoft Word ONLY
Approval date:
Approved consent version No.:
Leave blank for IRB Office Use.

You may use the oral assent script, the research assent form, or may rely
on the assent statement in the adult consent form (see instructional
template) to obtain assent. Include assent process in the research plan.
 Keep the language in brackets simple.
 Remove all the boxes and instructions in brackets below before printing
 Insert PI name and document version number in footer
ORAL ASSENT SCRIPT
For use in studies with children
We want to talk to you about a research study we are doing. A research study is a way
to learn information about something. We would like to find out more about [insert
purpose of study in simple language]. We are asking you to join the study because
[insert name of medical condition or other reasons for inclusion].
If you agree to join this study, you will be asked to
[describe procedures, (e.g., blood work, questionnaires, medication) in words a
child would know and understand. Also include number of visits and time frame
in words easily understood by a child].
[describe possible risks, e.g., discomforts and/or side effects in simple language].
We do not know if you will be helped by being in this study. We may learn something
that will help other children with [insert name of medical condition or subject matter
of study] some day.
You do not have to join this study. It is up to you. You can say okay now, and you can
change your mind later. All you have to do is tell us. No one will be mad at you if you
change your mind.
Before you say yes to joining this study, we will answer whatever questions you have.
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<< insert PI name and document version number>>
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